MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems Break (1069); Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Date 03/13/2023

Event Type  malfunction  

Event Description

Lipid filter came apart from tubing resulting in central line break.Central cultures drawn, antibiotics given.Patient was on total parenteral nutrition and lipids due to mucositis so had to throw out and hang specialty fluids due to line disconnect occurred at night.

• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 25212 w. illinois route 120; round lake IL 60073
• MDR Report Key: 16723791
• MDR Text Key: 313126947
• Report Number: 16723791
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/03/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/12/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 730 DA
• Patient Sex: Male